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Sorafenib Long Term Extension Program

Phase 3
16 Years
Open (Enrolling)

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Trial Information

Sorafenib Long Term Extension Program

Inclusion Criteria:

- Patients, who are participating in a previous Bayer/Onyx sponsored study that has
reached its endpoint (statistical and regulatory or study end), and who are, in the
opinion of the Investigator, expected to continue to have an overall positive
benefit/risk from continuing treatment.

- Patients who have signed informed consent for this long term extension program.

- Women of childbearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation, including the 30
days period after last study drug dosing. The investigator should advise the patient
how to achieve an adequate contraception.

- Women of childbearing potential who have a negative pregnancy test within 7 days of
the first dose of sorafenib in this long term extension program.

- Patient is receiving sorafenib (Nexavar) as a monotherapy in their originating
protocol. Patients who were being treated with sorafenib (Nexavar) in combination
with other chemotherapies in the original study, but continued on single agent
sorafenib (Nexavar) after discontinuation of the combination agent will be eligible.

- Patient who are receiving concurrent combination with sorafenib (Nexavar) and TACE
(transarterial chemoembolization) in their originating study will be eligible.

- Patients who have completed the End of Treatment assessments in their originating
study. Every effort should e made to conduct the End of Treatment visit such that
the patient does not have any interruption in sorafenib dosing.

Exclusion Criteria:

- Any condition that is unstable or which could jeopardize the safety of the patient
(please refer to the Investigator Brochure and product labeling safety sections).

- History of cardiac disease: congestive heart failure>NYHA Class 2 or uncontrolled

- Myocardial infarction (MI) within the last 3 months

- Symptomatic metastatic brain or meningeal tumors

- Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal
cell carcinoma, superficial bladder tumors ( Ta, Tis &T1) or any cancer curatively
treated > 5 years prior to study entry.

- Patients with seizure disorder requiring medication (such as steroid

- Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

- Any condition which could jeopardise the safety of the patient and his/her compliance
in the study

Excluded therapies and medications, previous and concomitant:

- Concurrent anti-cancer chemotherapy, except TACE (transarterial chemoembolization),
during or within 30 days prior to start of study drug

- Concurrent immunotherapy (including monoclonal antibodies),during or within 30 days
prior to start of study drug

- Concurrent hormonal therapy, except for bisphosphonates,during or within 30 days
prior to start of study drug

- Concomitant Rifampicin and St John's Wort (Warfarin may be used only with very close

- Radiotherapy during study or within 3 weeks of start of study drug. [Palliative
radiotherapy will be allowed]

- Concomitant use of potent inhibitors of CYP 3A4 including ketoconazole, itraconazole
and ritonavir. Consumption of grapefruit juice should also be avoided.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Long term safety of patients coming from completed sorafenib trials.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

December 2007

Completion Date:

July 2014

Related Keywords:

  • Neoplasms
  • Cancer
  • Sorafenib
  • Extension program
  • Neoplasms



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